Field of Invention
The present invention relates to a technical field of medical consumables, and more particularly to a repair material with multi-purpose for an abdominal wall hernia.
Description of Related Arts
Hernia is a fascial defect in structure. For example, an organ or part of the organ, or a tissue or part of the tissue is able to be extended through the fascial defect of an abdominal wall. Commonly, the hernia structurally comprises weakened, bulged or actually torn fascia of an organ or a tissue. There are many types of hernias. For example, if happening to a lower abdominal area, the hernia often contains intra-abdominal contents such as intestines or other tissues which enter or pass through the abdominal wall defect. Mesh patch is widely used in hernia repair. Conventionally, widely used patches are polyester meshes (such as Dacron and Mersilene), and polypropylene meshes (such as Marlex, Prolene, etc.). However, a simple non-degradable mesh is not suitable for intra-peritoneal implantation, because organ adhesions may occur with the patch, leading to serious complications such as infertility, chronic pelvic pain, intestinal fistula, intestinal obstruction, etc. A common solution is inserting a physical barrier at a position where adhesions are undesirable. However, this barrier leads to connecting problems in the interior of the barrier, because if the barrier is prepared by a non-absorbable material, the barrier itself becomes an adhesion source; if the barrier is absorbable, absorption must be non-inflammatory, for not leading to self-adhesion.
The ePTFE developed by Gore Company is an adhesion layer resistance product (Gore-Tex® Surgical Membrane), which provides effective tissue separation. However, the material is easy to cause infection, and must be removed through a second surgery after infection. In addition, due to a high material shrinkage rate, mesothelial cells are not able to grow into the material, so it is difficult to form a new peritoneum (Harrell A G, Novitsky Y W, Peindl R D, et al. Prospective evaluation of adhesion formation and shrinkage of intra-abdominal prosthetics in a rabbit model Am Surg 2006, 72: 808-14.).
International patent WO2009079271A2 discloses a Proceed multi-layer mesh developed by American Johnson & Johnson Company, wherein the multi-layer mesh comprises a polypropylene mesh layer, a poly-dioxanone layer (PDS) and an oxidized regenerated cellulose membrane layer (ORC). A composite method thereof comprises directly thermal-pressing an ORC knitted mesh having a certain moisture content with a PDS membrane and a polypropylene mesh, and increasing binding forces between different layers with the moisture content. However, a sample prepared by the method is easy to be separated, wherein the layers of the sample are able to be separated by a tensile testing machine, and softness thereof is poor, which means a compliance with the abdominal wall needs to be improved. As a result, there will be a strong foreign body sensation after implantation.
U.S. Pat. No. 6,451,032B1 discloses a Parietex mesh of Tyco Company, comprising a mesh woven by polyethylene terephthalate yarn, composite collagen, polyethylene glycol and glycerin; wherein a collagen solution is oxidized by periodic acid for self-crosslinking, and forms a first layer with the polyethylene glycol and the glycerol; a second layer is basically the same as the first layer. The first layer and the second layer are composited with the polyethylene terephthalate mesh for achieving multi-layer composite. According to the method, chemical reactions are involved and strong oxidizing agents are used. Furthermore, direct binding between the mesh and natural macromolecule collagen which is difficult to form a membrane is not stable.
Chinese patent CN101035574A and international patent WO 2005105172A1 both disclose a Sepramesh mesh developed by BARD Company, which is a double-layer mesh woven by polypropylene yarn and polyglycolic acid yarn. The double-layer is formed by immersing a polyglycolic acid layer in a modified hyaluronic acid/carboxymethyl cellulose solution and a modified polyethylene glycol solution, wherein the hyaluronic acid/carboxymethyl cellulose is crosslinked by a carbodiimide type crosslinking agent; a polyethylene glycol derivative is acrylate-terminated; and polymerization in the solution is initiated by light. Preparation of the product involves a lot of chemical reactions, which is complex and greatly increases manufacturing costs during production.
The above mentioned products have problems such as complicated preparation processes, a lot of chemical reactions, layers which are easy to be separated, poor softness and controversial anti-adhesion effects, and prices of the above products are very high.